NCT05474508

Brief Summary

The puerperium is a critical phase for women , not only does it have a significant impact on the mental and physical health of fresh mothers, but it can also be one of the most stressful moments in a woman's life .Serious psycho- social problems, including fatigue, depression, and stress, have been reported that occurred during the postpartum period. Diaphragm breathing method (DBE).DBE, also known as Diaphragmatic Breathing or Deep Breathing, is an effective holistic mind body workout for coping with stress and physical and mental conditions.Postpartum fatigue is considered the foremost common issue that postnatal ladies stand up to when they move to motherhood.postpartum fatigue is described as sentiments of fatigue,suffocation and diminishes in physical and mental capacity. This study will be a randomized clinical trial. Sample will be collected through convenient sampling technique.Randomization will be done through lottery method and patients will be divided into two groups. Group A will receive both aerobic exercises and diaphragmatic breathing exercise. B will receive only diaphragmatic breathing exercise. Data will be collected before and after treatment .data will be analyzed through SPPS 25.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

July 24, 2022

Last Update Submit

December 13, 2022

Conditions

StressFatigueSleep

Keywords

Diaphragmatic BreathingExerciseFatiguePostpartumStress

Outcome Measures

Primary Outcomes (3)

  • Perceived stress scale

    The Perceived Stress Scale is the most often used psychometric tool for assessing stress sensitivity. It is an assessment of how difficult things in one's life are perceived to be.

    6 Weeks

  • Pittsburgh sleep quality index

    The PSQI is a 19-item, self-reported questionnaire used to assess sleep quality.

    6 Weeks

  • Fatigue severity scale

    The FSS assessment has nine statements that assess the intensity of your tiredness symptoms. Read the information and mark a value from 1 to 7 depending on the how precisely it depicts your situation over the last week and how much you disagree or agree that now the claim pertains to yourself

    6 Weeks

Study Arms (2)

Diaphragmatic breathing along with aerobic exercises

EXPERIMENTAL

Experimental Group (Group A) will receive both aerobic exercises and diaphragmatic breathing exercise. Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks. Exercise protocol consist of at least 150 minutes of moderate-intensity aerobic activity every week dividing the 150 minutes into 30-minute workouts on 5 days of the week or into smaller 10-minute sessions throughout each day will be carried out for 6 weeks

Other: Diaphragmatic breathingOther: Aerobic exercises

Diaphragmatic breathing only without aerobic exercises

ACTIVE COMPARATOR

Active comparator (Group B) will receive only diaphragmatic breathing exercises. Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks.

Other: Diaphragmatic breathing

Interventions

Diaphragmatic breathingOTHER

Exercise programs will consist of 1 set of contractions per day and each set will include 30 repetitions for 6 weeks.

Diaphragmatic breathing along with aerobic exercisesDiaphragmatic breathing only without aerobic exercises
Aerobic exercisesOTHER

Exercise protocol consist of at least 150 minutes of moderate-intensity aerobic activity every week dividing the 150 minutes into 30-minute workouts on 5 days of the week or into smaller 10-minute sessions throughout each day will be carried out for 6 weeks.

Diaphragmatic breathing along with aerobic exercises

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with age group of 20- 40 were included in study.
  • Women who had Vaginal or c section delivery were included in study.
  • Women with no postnatal complications were included in study.

You may not qualify if:

  • Women who had a major operation within the last 3years were excluded.
  • Women who had chronic issues i.e diabetes, hypertension were excluded.
  • Women who had a history of psychiatric disorders were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital, gynae ward

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (5)

  • Buckley SJ. Executive Summary of Hormonal Physiology of Childbearing: Evidence and Implications for Women, Babies, and Maternity Care. J Perinat Educ. 2015;24(3):145-53. doi: 10.1891/1058-1243.24.3.145.

    PMID: 26834435BACKGROUND

  • Asadi M, Noroozi M, Alavi M. Factors Affecting Women's Adjustment to Postpartum Changes: A Narrative Review. Iran J Nurs Midwifery Res. 2020 Nov 7;25(6):463-470. doi: 10.4103/ijnmr.IJNMR_54_20. eCollection 2020 Nov-Dec.

    PMID: 33747834BACKGROUND

  • Kolovetsiou-Kreiner V, Moertl MG, Papousek I, Schmid-Zalaudek K, Lang U, Schlembach D, Cervar-Zivkovic M, Lackner HK. Maternal cardiovascular and endothelial function from first trimester to postpartum. PLoS One. 2018 May 21;13(5):e0197748. doi: 10.1371/journal.pone.0197748. eCollection 2018.

    PMID: 29782509BACKGROUND

  • Umazume T, Yamada T, Yamada S, Ishikawa S, Furuta I, Iwano H, Murai D, Hayashi T, Okada K, Morikawa M, Yamada T, Ono K, Tsutsui H, Minakami H. Morphofunctional cardiac changes in pregnant women: associations with biomarkers. Open Heart. 2018 Jul 16;5(2):e000850. doi: 10.1136/openhrt-2018-000850. eCollection 2018.

    PMID: 30057771BACKGROUND

  • Bett GC. Hormones and sex differences: changes in cardiac electrophysiology with pregnancy. Clin Sci (Lond). 2016 May 1;130(10):747-59. doi: 10.1042/CS20150710.

    PMID: 27128800BACKGROUND

MeSH Terms

Conditions

FatigueMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sabiha Arshad, M.Phil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2022

First Posted

July 26, 2022

Study Start

January 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 10, 2022

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)